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DBV Technologies SA

For the period ended Mar 31, 2024. Filed May 7, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 7, 2024

DBVT$10.45+6.6%Stored close · as of Nov 6, 2026

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Notes to the Condensed Consolidated Financial Statements (Unaudited)

NOTES TO THE CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form

10-K

filed with the SEC on March 7, 2024 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2023.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2024, or any other future period.

Use of estimates

The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.

On an

on-going

basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of

right-of-use

assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies

,

and (8) estimate of employee benefits obligations.

Going Concern

These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.

Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and

pre-clinical

spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the

6-month

safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.

Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/ Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol.

In December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch was completed at the end of February 2022 and has been prepared for FDA submission.

In May 2022, the Company established an

At-The-Market

(“ATM”) program allowing to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”). The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years.

During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million.

In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.

The company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.

Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024.

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of

non-dilutive

financings.

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The

COVID-19

pandemic and conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.

These Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.

Accounting Pronouncements recently adopted

There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.

There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.

Accounting Pronouncements issued not yet adopted

Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.

Note 2: Significant Events and Transactions

Clinical programs

United States Regulatory History and Current Status

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following

receipt of

the Complete Response Letter. The FDA agreed with its position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patch,

the

FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages

4-11.

The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a

6-month,

well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed the best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.

In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and on October 14, 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the

6-month

safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.

On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages

4-7

years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and

start-up

activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE phase 3 clinical study may proceed with the revised trial protocol.

On March 2, 2023, the Company announced the completion of EVOLVE, a

12-week

caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages

4–11-years

old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by the third quarter of 2024.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children

1-3

years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the

pre-specified

criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 –

3-years

and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 –

7-years

and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a

6-month

study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study.

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.

Viaskin Peanut for children ages

4-11—

European Union Regulatory History and Current Status

On August 2, 2021, the Company announced it received from the European Medicines Agency (EMA) the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (MAA) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES

(V712-301).

The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal clinical trial were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available.

Viaskin Peanut for children ages

1-3

In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study, subjects in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.

In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment arms.

The Company intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages

to

years, given the high unmet need and absence of approved treatments for this vulnerable population.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children

1-3

years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the

pre-specified

criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages

1-3

years old with a confirmed peanut allergy.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.

Viaskin Peanut for Children ages

4-7

On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages

4-7

years with peanut allergy.

The Company

defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

On September 21, 2022, the Company announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months,

the Company

engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition,

the Company

continued internal preparations for VITESSE and conducted certain site assessment and

start-up

activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last patient is anticipated by

the third quarter of

In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. In summary, there was an agreement with the Agency that COMFORT Children will be a Double-Blind, Placebo-Controlled study involving approximately 270 children, randomized at a 3:1 ratio (active to placebo). Participation will not necessitate a food challenge, and patch adhesion data will be generated using the same approach as previously agreed upon with the FDA for the VITESSE phase 3 study.

Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. Furthermore, the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). The revised protocol design of the safety study was submitted to the FDA in Q4 2023. COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment. The Company intends that enrollment of the COMFORT Children safety study will be strategically timed to avoid competition with the VITESSE study for the same subjects.

Legal Proceedings

From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of March 31, 2024 and December 31, 2023:

March 31,December 31,
20242023
Cash15,72510,530
Cash equivalents85,800130,836
Total cash and cash equivalents as reported in the statements of financial position101,525141,367
March 31,December 31,
20242023
Bank overdrafts——
Total cash and cash equivalents as reported in the statements of cash flows101,525141,367

Cash equivalents are immediately convertible into cash at no or insignificant cost,

on

demand. They are measured using level 1 fair value measurements.

Note 4

:

Other Current Assets

Other current assets consisted of the following:

March 31,December 31,
20242023
Research tax credit10,0668,857
Other tax claims5,7255,236
Prepaid expenses1,7272,103
Other receivables5181,353
Total18,03717,548

Research tax credit

The variance in Research Tax Credit is presented as follows:

Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 20248,857
+ Operating revenue1,407
- Payment received—
- Adjustment and currency translation effect(198)
Closing research tax credit receivable as of March 31, 202410,066
Of which - Non-current portion—
Of which - Current portion10,066

The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

Note 5

:

Lease contracts

Future minimum lease payments under the Company’s operating

leas

es’ right of use as of March 31, 2024 and December 31, 2023, are as follows:

March 31, 2024December 31, 2023
Real estateOther assetsTotalReal estateOther assetsTotal
Current portion344614051,205711,275
Year 21,014—1,014651175
Year 31,259—1,259421—421
Thereafter6,256—6,2565,515—5,515
Total minimum lease payments8,873618,9347,205817,295
Less: Effects of discounting(1,902)(7)(1,909)(1,617)(9)(1,626)
Present value of operating lease6,971547,0255,588735,670
Less: current portion(178)(54)(232)(1,072)(72)(1,144)
Long-term operating lease6,793—6,7934,51614,526
Weighted average remaining lease term (years)7.520.017.95—
Weighted average discount rate5.00%0.03%4.53%2.50%

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the condensed consolidated statement of operations and comprehensive loss was:

March 31,
20242023
Operating lease expense / (income)586446
Net termination impact(12)(81)

Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023:

20242023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases501496

Note 6: Trade Payables and Other Liabilities

6.1 Trade Payables

No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.

6.2 Other Current Liabilities

The following tables summarize the other current liabilities as of March 31, 2024 and December 31, 2023:

March 31 · December 31,
20242023
Other current liabilitiesOther non- current liabilitiesTotalOther current liabilitiesOther non- current liabilitiesTotal
Employee related liabilities4,629—4,6297,828—7,828
Tax liabilities180—180223—223
Other debts214—214883—883
Total5,023—5,0238,934—8,934

The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations as of March 31, 2024. The Employee related liabilities included short-term debt to employees including social welfare, tax agency obligations and bonus provision (paid during first quarter 2024)

as

of December 31, 2023.

Note 7: Shareholders’ equity

The share capital as of March 31, 2024 is set at the sum of €9,643,437 ($10,972 thousands converted at historical rates). It is divided into 96,434,369 fully authorized, subscribed and

paid-up

ordinary

shares with a par value of €0.10.

Note 8: Share-Based Payments

The Board of Directors has been authorized by the Shareholders General Meeting to grant restricted stock units (“RSU”), stock options (“SO”) and

non-employee

warrants (

Bons de Souscription d’Actions

or “BSA”).

During the three months ended March 31, 2024, the Company granted 262,000 stock options and 59,000 restricted stock units to employees.

There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.

Change in Number of BSA/SO/RSU:

Number of outstanding
BSASORSUs
Balance as of December 31, 2023244,6937,129,5412,021,370
Granted during the period—262,00059,000
Forfeited during the period—3,52513,738
Exercised/released during the period——2,598
Expired during the period———
Balance as of March 31, 2024244,6937,388,0162,064,035

Share-based payments expenses reflected in the condensed consolidated statements of operations is as follows:

Three Months Ended March 31,
2024 · 2023
Research & developmentSO(513)(429)
RSU(256)(258)
Sales & marketingSO(23)(27)
RSU(9)(8)
General & administrativeSO(1,030)(797)
RSU(126)(113)
Total share-based compensation (expense)(1,958)(1,632)

The $0.3 million increase in share-based compensation expenses is notably due to the increase of number of ordinary share equivalents granted in 2023 impacting the three months ended March 31, 2024, in comparison to the number granted in 2022 impacting the three months ended March 31, 2023.

Note 9: Contingencies

The following tables summarize the contingencies as of March 31, 2024 and December 31, 2023:

March 31,December 31,
20242023
Current contingencies3,1533,959
Non-current contingencies965935
Total contingencies4,1184,894

The changes in contingencies are as follows:

Pension retirement obligationsOther contingenciesTotal
At January 1, 20249353,9594,894
Increases in liabilities———
Used liabilities—(723)(723)
Reversals of unused liabilities(8)—(8)
Net interest related to employee benefits, and unwinding of discount———
Actuarial gains and losses on defined-benefit plans59—59
Currency translation effect(20)(82)(103)
At March 31, 20249653,1534,118
Pension retirement obligationsOther contingenciesTotal
Of which Current—3,1533,153
Of which Non-current965—965

In May 2016, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”) under which the Company was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program.

On October 30, 2023, the Company signed and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.

As of March 31, 2024, the accrual for ongoing Clinical study completion totals $1.3 million (vs. $2.3 million as of December 31, 2023) representing our best estimate of the remaining expenses related to the ongoing clinical study.

The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 to the consolidated financial statements included in the Annual Report.

Note 10: Operating income

The following table summarizes the operating income during the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,
20242023
Research tax credit1,4071,765
Other operating income—429
Total1,4072,194

As of March 31, 2023, other income were recorded according the Collaboration Agreement between the Company and NESTEC.

On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement, explaining the lack of other income as of March 31, 2024.

Note 11: Operating expenses

The Company had an average of 105 employees during the three months ended March 31, 2024, in comparison with an average of 87 employees during the three months ended March 31, 2023. This increase is mainly due to hiring to support clinical development activities related to ongoing and anticipated clinical trials and to support quality activities.

The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,
20242023
Research and Development expenses5,0484,006
Sales and Marketing expenses334165
General and Administrative expenses3,2363,100
Total personnel expenses8,6187,272

The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023:

Three Months Ended March 31,
20242023
Wages and salaries5,1444,438
Social security contributions1,207699
Expenses for pension commitments309258
Employer contribution to bonus shares—244
Share-based payments1,9581,632
Total8,6187,272

The increase in personnel expenses is mainly due to the recruitment of US employees.

Note 12: Financial income (expense)

Our financial income was $1.3 million for the three months ended March 31, 2024, compared to $0.6 million for the three

months

ended March 31, 2023. This item mainly includes the financial income on our financial assets.

Note 13: Commitments

There has beenno significant change in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.

Note 14: Relationships with Related Parties

There wereno new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.

Note 15: Loss Per Share

Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three months ended March 31, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months ended March 31, 2024 and 2023 indicated in number of potential shares:

Three Months Ended March 31,
20242023
Non-employee warrants244,693251,693
Stock options7,388,0165,318,569
Restricted stock units2,064,0351,583,938
Prefunded warrants28,276,33128,276,331

Note 16: Events after the Close of the Period

The Company evaluated subsequent events that occurred after March 31, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 7, 2024 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

On April 22, 2024, the Company moved its headquarters to 107 Avenue de la République in Châtillon in France, which is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.

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